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Mesenchymal Stem Cells in Central Nervous System injury2017

NCT03291366 — Phase 1 / Phase 2, Unknown, 30 participants, Fuzhou General Hospital

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Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017

RegistryNCT03291366
StatusUnknown
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment30 (Estimated)
SponsorFuzhou General Hospital (Other)
ConditionsCentral Nervous System Injury
InterventionsUCMSCC, conventional treatment (Drug)
Datesstart 2017-01-01, primary completion 2020-01-01 (estimated), completion 2022-01-01 (estimated), first posted 2017-09-25, last updated 2017-09-25

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-Summary

Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.

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+Arms and interventions

ArmTypeInterventionsDescription
MSCExperimentalDrug: UCMSCC; Drug: conventional treatmentinfusion of aUCMSC and conventional therapy
conventionalActive comparatorDrug: conventional treatmentconventional therapy
  • UCMSCC (Drug): infusion of aUCMSC and conventional therapy
  • conventional treatment (Drug): conventional treatment

+Outcome measures

Primary outcomes

  • life quality score [1y]

Secondary outcomes

  • adverse events [1y]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* CNS injury > 3 months
* age > 18 years
* willing to give consent
* stable vital signs
* absence of active infectcion

Exclusion Criteria:

* any contradiction to intrathecal infusion
* age < 18 years
* CNS injury < 3 months
* CNS injury > 3 years

My Notes